Manufacturer

GE Healthcare, LLC

475 recalls in our database name GE Healthcare, LLC as the manufacturing or recalling firm.

What the numbers show

Total: 475
Critical: 8
Severe: 43
Most recent: 2026-04-08

Of the 475 recalls from GE Healthcare, LLC we have scored against our rubric, 8 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 43 (9%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

201–225 of 475

HighFDA (Devices)·Z-1878-2019·2019-07-03
GE Healthcare Recalls ECG Leadwire Sets Due to Defibrillation Risk
GE Healthcare is recalling specific ECG leadwire sets because they may reduce energy delivery during defibrillation, potentially limiting the success of the procedure.
Product
Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 in 2106381-002 ECG Leadwire set, 5-lead, snap, AHA, 130 cm/ 51 in 2106381-003 ECG Leadwire set, 5-lead, snap, IEC, 74 cm/ 29 in 2106381-004 ECG Leadwire se
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1876-2019·2019-07-03
GE Healthcare Recalls ECG Leadwire Sets Due to Defibrillation Risk
GE Healthcare is recalling ECG leadwire sets because they may reduce energy reaching patients during defibrillation, potentially limiting treatment success.
Product
ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 74 cm/ 29 in 2106389-002 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 130 cm/ 51 in 2106389-003 ECG Leadwire set, 5-lead, grouped, grabber, IEC, 74 cm/ 29 in 2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1879-2019·2019-07-03
GE Healthcare Recalls Replacement ECG Leadwires Due to Defibrillation Risk
GE Healthcare is recalling 58,045 replacement ECG leadwires worldwide because they may reduce energy delivery during defibrillation, potentially limiting the success of the procedure.
Product
Replacement ECG leadwires with snap ends REF/Catalog Number Description 2106386-101 Replacement ECG Leadwire, snap, LL, AHA, 130 cm/ 51 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1875-2019·2019-07-03
GE Healthcare Recalls ECG Trunk Cables Due to Defibrillation Risk
GE Healthcare is recalling ECG trunk cables that may reduce energy delivery during defibrillation, potentially limiting the success of the procedure.
Product
ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 m/12 ft. 2106305-002 ECG Trunk Cable, 3/5-lead, AHA, 1.2 m/4 ft. 2106305-003 ECG Trunk Cable, 3/5-lead, IEC, 3.6 m/12 ft. 2106305-004 ECG Trunk Cable, 3/5-lead, IEC, 1.2 m/4 ft.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1748-2019·2019-06-26
GE Healthcare Discovery IQ PET/CT Systems Recalled for X-Ray Exposure Defect
GE Healthcare is recalling 1,113 Discovery IQ PET/CT systems because the table may stop moving while X-ray exposure continues.
Product
Discovery IQ Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1747-2019·2019-06-26
GE Healthcare Recalls Optima PET/CT Systems Due to X-Ray Exposure Hazard
GE Healthcare is recalling 1,113 Optima PET/CT 560 and 560FX systems because the table may stop moving while X-ray exposure continues.
Product
Optima PET/CT 560, 560FX Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1749-2019·2019-06-26
GE Healthcare Recalls Discovery ML PET/CT Systems Due to X-Ray Safety Defect
GE Healthcare is recalling 1,113 Discovery ML PET/CT systems because the table may stop moving without stopping X-ray exposure.
Product
Discovery Ml Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1750-2019·2019-06-26
GE Healthcare Recalls Discovery ML DR PET/CT Systems Due to Table Stop Defect
GE Healthcare is recalling 1,113 Discovery ML DR PET/CT systems because the table may stop moving without stopping X-ray exposure.
Product
Discovery Ml DR Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1745-2019·2019-06-26
GE Healthcare Recalls Discovery PET/CT 610 Systems Due to X-Ray Safety Issue
GE Healthcare is recalling 1,113 Discovery PET/CT 610 systems because the table may stop moving while X-ray exposure continues.
Product
Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1746-2019·2019-06-26
GE Healthcare Recalls Discovery PET/CT 710 Systems Due to Table Stop Defect
GE Healthcare is recalling 1,113 Discovery PET/CT 710 systems because the table may stop moving without stopping X-ray exposure.
Product
Discovery PET/CT 710 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1839-2019·2019-06-26
GE Healthcare Recalls Vscan Extend Ultrasound Devices Due to EF Calculation Bias
GE Healthcare is recalling 119 Vscan Extend ultrasound devices because the LVivo EF app may overestimate ejection fraction values, potentially affecting clinical assessments.
Product
LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vscan Extend Dual USB, Model Number H41212RK; c. Vscan Extend Dual Wi-Fi, Model Numbers H41212YZ, H41212RL; d. Vscan Extend
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1753-2019·2019-06-19
GE Healthcare Recalls Prestilix 1600X Digital Radiology Systems
GE Healthcare is recalling 825 Prestilix 1600X digital radiology systems because a monitor fell off its wall mount due to product aging.
Product
Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology applications with or without contract injection and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1755-2019·2019-06-19
GE Healthcare Recalls Silhouette VR Systems Due to Monitor Mount Failure
GE Healthcare is recalling 825 Silhouette VR systems because a CRT monitor fell off its wall mount due to product aging.
Product
Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum performance all in a space-saving design.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1752-2019·2019-06-19
GE Healthcare Recalls Proteus XR/a Radiographic Systems Due to Monitor Fall Risk
GE Healthcare is recalling 825 Proteus XR/a radiographic systems because a monitor fell off its wall mount due to product aging.
Product
Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your specific requirements. The system provides exceptional image quality, high frequency X-ray generation, easy patient positioning, intuitive operator control and m
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1781-2019·2019-06-19
GE Centricity PACS-IW Recall for Potential Missing Image Series
GE Healthcare is recalling 620 units of Centricity PACS-IW software because image series may be missing from exams without a warning.
Product
GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1751-2019·2019-06-19
GE Healthcare Recalls Prestige Systems Due to Monitor Mount Failure
GE Healthcare is recalling Prestige II, SI, and VH systems because a CRT monitor fell off its wall mount due to product aging.
Product
Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional and digital R/F remote controlled system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1754-2019·2019-06-19
GE Healthcare Precision 500D X-ray System Recall for Monitor Mount Failure
GE Healthcare is recalling Precision 500D X-ray systems because a CRT monitor fell off its wall mount due to product aging.
Product
Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1257-2019·2019-05-08
GE Healthcare Recalls Discovery NM 630 Nuclear Imaging Systems
GE Healthcare is recalling 57 Discovery NM 630 nuclear imaging systems because detector screws may not be secured correctly, risking loss of mounting redundancy.
Product
Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1261-2019·2019-05-08
GE Healthcare Recalls NM 830 Nuclear Imaging Systems for Screw Defect
GE Healthcare is recalling 37 Discovery NM 830 nuclear imaging systems because detector screws may not be secured correctly, potentially compromising mounting redundancy.
Product
NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various a
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1259-2019·2019-05-08
GE Discovery NM/CT 670 DR Recalled for Potential Detector Screw Issue
GE Healthcare is recalling 11 Discovery NM/CT 670 DR systems because detector screws may not be secured correctly, potentially compromising mounting redundancy.
Product
Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormal
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1263-2019·2019-05-08
GE Healthcare Recalls NM/CT 860 Systems Due to Detector Screw Issue
GE Healthcare is recalling six NM/CT 860 systems because detector screws may not be secured correctly, potentially compromising mounting redundancy.
Product
NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1262-2019·2019-05-08
GE Healthcare Recalls NM/CT 850 Systems Due to Detector Screw Issue
GE Healthcare is recalling 31 NM/CT 850 systems because detector screws may not have been secured correctly, potentially compromising mounting redundancy.
Product
NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by v
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1266-2019·2019-05-08
GE Healthcare Recalls Optima NM/CT 640 Systems for Detector Screw Issue
GE Healthcare is recalling 35 Optima NM/CT 640 systems because detector screws may not have been secured correctly, potentially compromising mounting redundancy.
Product
Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1258-2019·2019-05-08
GE Healthcare Recalls Discovery NM/CT 670 CZT Systems for Mounting Defect
GE Healthcare is recalling three Discovery NM/CT 670 CZT systems because detector screws may not be secured correctly, potentially compromising detector mounting redundancy.
Product
Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medici
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1265-2019·2019-05-08
GE Healthcare Recalls 27 NM/CT 870 DR Systems Due to Detector Screw Issue
GE Healthcare is recalling 27 NM/CT 870 DR systems because detector screws may not be secured correctly, potentially compromising detector mounting redundancy.
Product
NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and
Category
Medical Device
Distribution
0 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

GE HealthCare

American multinational medical technology company

Country: United States
Founded: 2004

Official website

Source: Wikidata (Q1152374), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.